63 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FASTPACK CONTROL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033222·Basin Pack, Cardiac
VIRTUOST
FDA 510(k)
FDA Class 2
·Radiology
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019
HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BWF·May 14, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 26, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016
GMK-REVISION FEMUR REVISION PS SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019
GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 28, 2019
GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 10, 2024
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/20MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 23, 2023
3005180920-2018-00592
FDA Adverse Event
Injury
·July 31, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2024